MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 76446535

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Radiographic image result: post-op image for l5-s1 fusion ap and lateral x-ray provided.At last one of the s1 screw is fractured.Fusion status is unknown, there may also be a fracture of the rod above the crosslink at l4, l5 as well.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via field representative regarding patient with lumbar spinal stenosis involved in spinal therapy.It was reported that post-op, screw rod broke and fragments left in the patient.There were patient symptoms or complications reported as a result of the event.Patient symptom-osphyalgia (pain in the lumbar region) was reported.Additional information received that lumbar 5 and sacral 1 screws were broken.Patient achieved solid fusion.Patient is alive.On (b)(6) 2020, received additional information that revision surgery performed to the patient.The implantation has been removed.However, only the tip side of the broken screw has been removed, and some screw rod remained in the patient's body.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

D3: correction mfr name, street 1, mfr city, mfr region, postal code is corrected.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: device evaluated summary: visual examination revealed the screw was broken about 3 threads down from the base of the bone screw head.Optical examination of the area of fracture initiation did not identify a pre-existing surface defect that could contribute to the break.Microscopic examination of the fracture surface identified a fairly flat fracture surface with progressive striations consistent with cyclic fatigue.This type of damage is consistent with cyclic fatigue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• MDR Report Key: 10501551
• MDR Text Key: 205910566
• Report Number: 1030489-2020-01232
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00885074134734
• UDI-Public: 00885074134734
• Combination Product (y/n): N
• PMA/PMN Number: K042025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 76446535
• Device Catalogue Number: 76446535
• Device Lot Number: H5334962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 09/28/2020; 02/23/2021
• Supplement Dates FDA Received: 09/16/2020; 09/30/2020; 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR